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Intraarticular Corticosteroid Therapy in Perthes Disease.

This study has been terminated.
(low recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01026909
First Posted: December 7, 2009
Last Update Posted: January 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Klane White, Seattle Children's Hospital
Results First Submitted: November 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Legg-Calve Perthes Disease
Intervention: Drug: Aristospan 20mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Injection Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
Control Observation

Participant Flow:   Overall Study
    Injection   Control
STARTED   1   2 
COMPLETED   1   2 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Injection Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
Control observation
Total Total of all reporting groups

Baseline Measures
   Injection   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   2   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 9  (0)   7.33  (2.08)   7.33  (2.08) 
Age 
[Units: Participants]
     
<=18 years   1   2   3 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   1   0   1 
Male   0   2   2 
Region of Enrollment 
[Units: Participants]
     
United States   1   2   3 


  Outcome Measures
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1.  Primary:   Primary Outcome Variable: Function. The Pediatric Outcomes Data Collection Instrument (PODCI) Will be the Primary Endpoint as a Measure of Function and Health Related Quality of Life at 12 Months Post Injection.   [ Time Frame: This exam is to be administered at time of enrollment and at 4 and 12 months follow up visits. ]

2.  Secondary:   Second Outcome Variable: Ambulatory Activity. It Will be Defined as Average Steps/Day as Measured by the StepWatch Activity Monitor for a 7 Day Sample.   [ Time Frame: StepWatch monitor will be used 7 days prior to treatment and 4 weeks, 4 months and 12 months follow up visits ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Klane White
Organization: Seattle Children's Hospital
phone: 206-987-5678
e-mail: klane.white@seattlechildrens.org



Responsible Party: Klane White, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01026909     History of Changes
Other Study ID Numbers: AEF-24812
First Submitted: October 6, 2009
First Posted: December 7, 2009
Results First Submitted: November 22, 2014
Results First Posted: January 29, 2016
Last Update Posted: January 29, 2016